IntraBiotics Pharmaceuticals Inc has reached Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) on the design of the pivotal trials to be conducted in support of registration of iseganan for use in patients receiving mechanical ventilation to reduce the risk of pneumonia (hereafter referred to as prevention of ventilator-associated pneumonia - VAP).
The SPA letter from the FDA documents the agreed upon terms and conditions under which IntraBiotics will conduct and analyze the data from two identical pivotal, randomized, double-blind, placebo-controlled, multinational clinical trials. The Company expects to begin enrollment in the first trial by the end of September and to complete that trial and announce its results by the end of 2004.
Earlier this month, the Company announced that the FDA granted iseganan fast-track designation for this development program.
"We have appreciated our collaboration with the FDA throughout the SPA process on this development program, which has been designed to address an unmet medical need for mechanically-ventilated patients who are at high risk for developing VAP. Having the same endpoint for both trials enables us to have a good sense of whether iseganan will be successful upon completion of the first trial. Agreement with the FDA on the design of these clinical trials is important to assure expeditious registration if the trials are successful," said Dr. Henry Fuchs, President and CEO of IntraBiotics.
Following successful completion of the studies, the Company would expect to file a New Drug Application (NDA).